Curis opts in to Genentech BCC development

Curis, a therapeutic drug development company, has elected to exercise a co-development option with its collaborative partner, US biotech giant Genentech, and will now share in US development costs and future net profits, if any, derived from sales in the US of a therapeutic product candidate for the topical treatment of basal cell carcinoma.

Basal cell carcinoma, a skin cancer, is the most common form of all human cancers with approximately 800,000 to 1,000,000 new cases every year in the US.

Daniel Passeri, Curis' president and chief executive officer, commented: 'Our election to exercise the co-development option represents another step forward in the implementation of our business model that specifies a diversified development approach for our broad product portfolio. We believe that co-development may provide a means of managing the risk of clinical development while at the same time allowing us to retain greater upside potential on certain promising programmes. We have a high degree of confidence in our collaborative partner, Genentech, and in the science that underlies the basal cell carcinoma product candidate.'

Curis plans to assist Genentech in filing an Investigational New Drug application with the FDA in order to initiate human clinical investigation of the basal cell carcinoma product candidate. In June 2003, Curis established a collaboration with Genentech for the continued development of a set of anti-cancer technologies based on inhibition of the Hedgehog signaling pathway, including small molecule Hedgehog pathway inhibitors. Under the terms of the collaboration, Curis retained a co-development option to share in development costs and future net profits, specifically for one of the small molecule Hedgehog pathway inhibitors. This co-development right applies solely to the US marketplace and includes applications for basal cell carcinoma and any additional indications for which this product candidate may be developed.

Curis expects that by exercising this co-development and equal cost-sharing option it will incur approximately $20m in development expenses through Phase II clinical trials, a portion of which will be booked in the first quarter of 2005. Assuming the acceptance of the IND application by the FDA and the successful advancement of the basal cell carcinoma product candidate through Phase I and Phase II clinical trials, the company expects that the Phase II clinical trial will be completed in mid-2007. Curis expects to incur additional costs to complete Phase III clinical trials and complete the regulatory approval process, assuming that the parties successfully complete Phase II clinical trials. In exchange for this investment, Curis has increased its downstream revenue potential, through its right to a commensurate share in US net profits, if any. In addition to the US market, Curis will receive milestones if specific development objectives are achieved and a royalty on any international sales of the topical Hedgehog antagonist.

To date, preclinical evidence indicates that inhibition of the Hedgehog pathway in basal cell carcinoma results in the selective and specific death of the tumour cells while conferring no harm to adjacent normal cells.

About Basal Cell Carcinoma

Basal cell carcinoma is a skin cancer and the most common form of cancer in the U.S. It accounts for about 75% of all skin cancers. The incidence of skin cancer has increased greatly in recent years, due in part to greater exposure to UV radiation from the sun. In 1990, 600,000 Americans were diagnosed with basal cell carcinoma up from 400,000 in 1980. It is currently estimated that there are between 800,000 and 1,000,000 new cases of basal cell carcinoma each year in the United States. Basal cells are normal skin cells. They may develop cancerous changes, causing a lump or bump that is painless. A new skin growth that ulcerates, bleeds easily, or does not heal well may indicate development of basal cell skin carcinoma. More than 90% of basal cell carcinomas occur on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation, primarily the face. The onset of basal cell carcinoma most commonly occurs after age 40.